Surfacer® Inside-Out® Access Catheter System

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Surfacer® Inside-Out Access system - Restore Access, Preserve Options - Merit Medical

RESTORE ACCESS. PRESERVE OPTIONS.

In patients with chronically occluded central veins, the current approach is to move to another vein if a subsequent central venous catheter (CVC) is needed. Failed venous access attempts may prevent permanent arteriovenous (AV) access, increasing patient morbidity and the overall cost of care.1

Features & Benefits

To restore and preserve access in chronically occluded veins, John Gurley, M.D.2 developed the Inside-Out approach – allowing clinicians to change the standard of care.

Restore Access and Sustain Central Venous Access

Image of full access entry point on patient
  • Achieves repeatable and reliable central venous access to the right internal jugular (RIJ) vein
  • Preserves the viability of secondary central veins
  • Optimizes placement and maturation of permanent AV access

Reliable Procedure

Central venous access point on patient
  • 100% (12 of 12) of patients underwent successful central venous access placement3
  • 100% (12 of 12) of patients maintained patency of central venous access through long-term follow-up visit3
  • No device-related adverse events were reported within 48 hours and at 14-day follow-up visit3

Reduce Costs

View of patient neck with Surfacer entry point
  • Supports the achievement of permanent AV access which reduces hemodialysis provider cost and downtime by decreasing catheter-associated morbidity and complications1
  • Easier, minimally invasive procedure compared to surgical bypass for patients with totally occluded central veins

Inside-Out Approach

To restore and preserve access in chronically occluded veins, John Gurley, M.D. developed the Inside-Out approach – allowing clinicians to change the standard of care.

The Surfacer System is inserted through the femoral vein and navigated to an exit point in the right internal jugular (RIJ) vein. This proprietary Inside-Out approach achieves access to an occluded RIJ vein while preserving the viability of secondary central veins.

Totally Occluded Superior Vena Cava

Totally occluded superior vena cava

Exit Target Provides a Zone to Position the Surfacer Device to Exit the Skin

Exit target provides a zone position to Surfacer Device to exit the skin

Introducer Sheath Locked Onto Needle Wire and Pulled Into Right Atrium

Introducer Sheath Locked Onto Needle Wire and Pulled Into Right Atrium

Clinical Studies

SAVE STUDY (Status: Completed)

The SAVE ( Surfacer System to Facilitate Access in Venous Occlusions) Clinical Study is designed to confirm clinical performance and safety of the Surfacer Inside-Out Access Catheter System to facilitate the entry and placement of central venous access catheters in patients with limited or diminishing upper body venous access.

Design and Methodology

  • Prospective, multicenter, post market clinical follow-up study
  • Patients referred for placement of a central venous catheter (CVC) and who meet the inclusion and exclusion criteria

Primary Endpoints

  • Performance
  • Safety

TO LEARN MORE, CONTACT BLUEGRASS TECHNOLOGIES.

FIRST-IN HUMAN STUDY (Status: Complete)

The first-in-human study was designed to assess the safety and feasibility of the Surfacer Inside-Out Access Catheter System.

Design and Methodology

  • Single-center feasibility study
  • N=12 patients with compromised upper venous occlusive disease

Results

All 12 patients received an access catheter, which remained in place and functional throughout long-term follow-up of 14 days. Results demonstrate this novel Inside-Out approach provides safe and effective percutaneous central venous access, despite chronic occlusion of the superior vena cava.

Surfacer First In-Human Study Results

E.U. Post-market Clinical Experience with Surfacer System White Paper

TO LEARN MORE, VIEW THE ARTICLE PUBLISHED IN ENDOVASCULAR TODAY

REFERENCES

  1. Data on file
  2. Department of Cardiology, University of Kentucky, Lexington, KY, USA.
  3. Ebner A, Gallo S, Cetraro C, Gurley J, Minarsch L. Inside-Out Upper Body Venous Access: The first-in-human experiences with a novel approach using the Surfacer Inside-out Access Catheter System. Endovascular Today. June 2013.
    • a. Mild hematoma at the clavicular exit due to tunneling and unrelated to the Surfacer device. Manual compression was not required.
    • b. At 48-hour and 14-day follow-up unrelated to the Surfacer device. Manual compression was not required.
    • b. At 48-hour and 14-day follow-up.

Documents

Discover more about the Surfacer Inside-Out Access Catheter System by reviewing the brochures and Instructions for Use.

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